[ Price : $8.95]
FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for ...[ Price : $8.95]
FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovar...[ Price : $8.95]
HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies,...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file deci...[ Price : $8.95]
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.[ Price : $8.95]
FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Food, Drug, and Cosmetic Act as ...[ Price : $8.95]
President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agree...[ Price : $8.95]
FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/...